[MYCOBACTERIOSIS ASSOCIATED WITH ADMINISTRATION OF BIOLOGICS]

Area of Science:

• Immunology
• Rheumatology
• Infectious Diseases

Background:

• Biologic therapies, particularly TNF-α inhibitors, are increasingly used for inflammatory diseases like rheumatoid arthritis.
• These treatments can increase the risk of opportunistic infections, including tuberculosis (TB) and non-tuberculous mycobacteriosis (NTM).
• Japan has a high prevalence of past tuberculosis exposure, raising concerns about TB reactivation with biologic use.

Purpose of the Study:

• To evaluate the risk of tuberculosis complications in patients receiving biologics for inflammatory diseases.
• To assess the effectiveness of preventive strategies for tuberculosis in this patient population.
• To explore the safety and potential benefits of biologic administration in cases of non-tuberculous mycobacteriosis.

Main Methods:

• Analysis of post-marketing surveillance data in Japan.
• Review of clinical cases involving tuberculosis and non-tuberculous mycobacteriosis in patients on biologics.
• Evaluation of screening protocols for latent tuberculosis infection (LTBI) and prophylactic anti-tuberculosis drug administration.

Main Results:

• Screening for LTBI and preemptive anti-tuberculosis treatment significantly reduced tuberculosis incidence in patients initiating TNF-α inhibitors.
• Despite prophylaxis, some patients developed severe, fatal tuberculosis, potentially due to immune reconstitution inflammatory syndrome (IRIS).
• Non-tuberculous mycobacteriosis (NTM) is increasing, and while previously contraindicated, biologics may be cautiously administered under specific conditions.

Conclusions:

• Prophylactic measures are effective but not fully protective against tuberculosis reactivation during biologic therapy.
• Management of potential IRIS is critical, possibly requiring re-administration or continuous use of biologics.
• Biologic therapy for NTM may be feasible in select cases, warranting further investigation.